Scottish Trial of Arthroplasty or Reduction for Subcapital fractures (STARS)
ISRCTN | ISRCTN32884890 |
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DOI | https://doi.org/10.1186/ISRCTN32884890 |
Secondary identifying numbers | HTA 94/24/03 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 10/07/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr John Keating
Scientific
Scientific
Department of Orthopaedics
University of Edinburgh
Royal Infirmary
Little France
Old Dalkeith Road
Edinburgh
EH16 4SU
United Kingdom
Phone | +44 (0)131 242 3436 |
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johnkeating@ed.ac.uk |
Study information
Study design | Prospective randomised multicentre trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | Scottish Trial of Arthroplasty or Reduction for Subcapital fractures (STARS) |
Study acronym | STARS |
Study objectives | In a prospective randomised multicentre trial we will evaluate the management of displaced subcapital fractures in fit elderly patients with bipolar hemiarthroplasty, total hip arthroplasty or reduction and fixation. The trial will be conducted under the auspices of the Scottish Orthopaedic Trial Network, which involves the four university orthopaedic centres and associated district general hospitals. Patients will be randomised to one of three treatment groups and will be followed up for a minimum of two years. Please note that, as of 11/05/2009, the anticipated end date has been updated from 31/08/2000 to 31/08/2002. |
Ethics approval(s) | Not provided at time of registration. |
Health condition(s) or problem(s) studied | Injury, occupational diseases, poisoning: Musculoskeletal injury |
Intervention | There are three treatment options: 1. One method of mending the break is with a type of screw, sometimes with a plate on its side; the two parts of the bone are joined together, and no bone is replaced. 2. A second method using a hip replacement. The ball at the end of the femur bone is replaced by an artificial 'ball' which is fixed into the top of the rest of the femur bone; the socket is not replaced. 3. The third method is also a type of hip replacement. Like the second method, the ball of the femur is replaced, but the socket in the hip bone is also replaced. |
Intervention type | Other |
Primary outcome measure | Clinical outcome will include perioperative mortality and reoperation. Functional outcomes will be assessed using a hip rating questionnaire and the EuroQoL functional outcome questionnaire. A cost-effectiveness and cost utility analysis will be integrated into the study protocol. |
Secondary outcome measures | Not provided at time of registration. |
Overall study start date | 01/06/1996 |
Completion date | 31/08/2002 |
Eligibility
Participant type(s) | Patient |
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Age group | Senior |
Sex | Not Specified |
Target number of participants | 298 |
Total final enrolment | 298 |
Key inclusion criteria | Elderly patients with bipolar hemiarthroplasty, total hip arthroplasty or reduction and fixation. |
Key exclusion criteria | Not provided at time of registration. |
Date of first enrolment | 01/06/1996 |
Date of final enrolment | 31/08/2002 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Department of Orthopaedics
Edinburgh
EH16 4SU
United Kingdom
EH16 4SU
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
Phone | +44 (0)1132 545 843 |
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Sheila.Greener@doh.gsi.gov.uk | |
Website | http://www.dh.gov.uk/en/index.htm |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/10/2005 | Yes | No |
Editorial Notes
10/07/2019: Total final enrolment added.